Orange Book Blog

ACI will be holding its always-popular "Paragraph IV Disputes" conference in New York City next week, on May 7-8.  This year's conference–the 7th annual–looks better than ever.  The agenda includes the following presentations:

• Anticipating a Paragraph IV Challenge: New Considerations in Light of AIA and the Patent Cliff
• Asserting Invalidity or Non-infringement Under Paragraph IV: Exploring the ANDA Applicant's Pre-litigation Obligations and Options
• Safe Harbor or Stormy Port?: Analyzing How New 271(e)(1) Controversies Will Impact Paragraph IV Disputes
• Throwing Down the Gauntlet: The Paragraph IV Notice Letter
• Obviousness in Retrospect: Making Sense of Prior Art, Obviousness-Type Double Patenting, Inherency and New AIA Controversies
• Let the Games Begin: The Start of the Paragraph IV Law Suit — Pleadings and Other Considerations
• A View From the Bench — with Hon. Paul R. Michel, Hon. Gregory M. Sleet, Hon. Stanley R. Chesler, Hon. Joel A. Pisano, Hon. Tonianne Bongiovvani, and Hon. Garrett E. Brown
• Pay-for-Delay Update — presented by Markus H. Meier, Asst. Dir., Health Care Division, Bureau of Competition, Federal Trade Commission
• Settlement of Paragraph IV Law Suits: The Industry Perspective
• Parallel and Alternate Proceedings in Paragraph IV Disputes: Seeking Simultaneous or Sole Redress Before the PTO, ITC and Other Alternative Forums — with Hon. Garrett E. Brown, Mon. Mary Pat Thynge, Hon. Joseph A. Dickson, Hon. James Donald Smith, and Hon. Robert K. Rogers
• FDA Proceedings and Regulatory Developments Impacting Paragraph IV Litigation
• New Exclusivity Challenges: Brand Names Take Notice — It's Not Just a Concern for Generics Anymore
• Examining New Rulings in Inducement of Infringement and Divided Infringement and Their Application to Method Claims in Hatch-Waxman Litigation
• New Developments in Damages Theories and Injunctions Relative to At-Risk Launches: Legal and Economic Assessments
• Inequitable Conduct Developments in the Courts and at the PTO: Ethical Considerations for Paragraph IV Cases

In addition to the main conference, ACI is offering two pre-conference workshops on May 6.  In the morning will be Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals; and in the afternoon, Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation.  Finally, on May 9 ACI is offering a post-conference Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand Names and Generics — A Hands-On, Practical Approach.

Orange Book Blog readers are eligible for a discounted registration rate by using code OBB 200.  For additional information or to register, please visit the conference website.